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The Amplatzer Talisman Delivery Sheath is indicated to provide a pathway through which an Amplatzer™ PFO Occluder is introduced for patent foramen ovale closure.

The Amplatzer Talisman Delivery Sheath is a line extension of the Amplatzer Trevisio Intravascular Delivery System. The Amplatzer Talisman Delivery Sheath is a single use sheath intended to facilitate the delivery and deployment of the Amplatzer Talisman PFO Occluder. The delivery sheath is available in 8F and 9F sizes with a 45° curve and 80 cm usable length. The sheath and dilator are radiopaque for visibility under fluoroscopy. For added visibility the sheath also has a platinum/iridium marker band near the distal tip. The Talisman Delivery Sheath is comprised of two components: a dilator to ease penetration of tissue and minimize vessel trauma, and a sheath to provide a pathway through which an Amplatzer occluder is delivered

The provided text describes the regulatory clearance of a medical device, the Amplatzer Talisman Delivery Sheath, and references various tests and studies conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria or detailed results of a study in a format that would allow for the direct completion of the requested table and detailed description.

The document states that "Bench testing, including shelf life testing, was conducted to demonstrate that the Amplatzer Talisman Delivery Sheath met all performance specifications" for items like "Dimensional", "System Leak", "Handoff Force", etc. It also mentions "Design Validation studies" and an "acute animal study." However, it does not provide the numerical acceptance criteria for these specifications nor the quantitative results that prove the device met them.

Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, or expert details for the studies, as this specific information is not present in the provided text.

The document focuses on confirming that certain types of tests were performed and that the device was deemed "substantially equivalent" based on these tests, without detailing the quantitative outcomes of those tests against specific acceptance criteria.

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